(Mass Tort Nexus Media) Litigation against OxyContin maker Purdue Pharma LP and the rest of the Opioid Big Pharma industry just jumped significantly, as six more states have filed lawsuits against Purdue Pharma, et al. The ongoing allegations against the opioid pharmaceutical industry as a whole, where numerous governmental entities from across the country have asserted that the opiate makers have fueled a national opioid crisis. This is primarily based on corporate boardroom designed deceptive opioid marketing campaigns, designed to sell prescription opioids, and minimize the previously well-known medical risks, including addiction and overdose, while generating billions of dollars in sales.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

State attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee assert that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

Teva, in a statement, emphasized the importance of safely using opioids, while AmerisourceBergen said it was committed to collaborating with all stakeholders to combat opioid abuse.

The Healthcare Distribution Alliance, an umbrella group for drug distributors, said in a statement that accusations that distributors were responsible for the abuse of opioid prescriptions defied common sense and lacked understanding of the pharmaceutical supply chain.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small. Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

THE SACKLERS AND PURDUE

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country. At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

PURDUE-OXYCONTIN HISTORY

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What’s more, Purdue Pharma’s patent for the original OxyContin formula didn’t expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

OxyContin’s ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors’ offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn’t make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?

During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

“FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

Former President Bill Clinton pulled no punches as he focused directly on the opiate issues “Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game rests, which is one of the prime issues of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered. Clinton further commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

RURAL vs. BIG CITY OPIATES

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these states, with West Virginia numbers being, 780 million painkillers prescribed in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a point where Opiate Big Pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to assign a financial penalty for the alleged corporate opioid abuses.

FDA Failed to Cite Opioid Big Pharma

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

As the Opioid litigation expands across the country in both state and federal courtrooms, it remains to be seen if the anticipated payouts will surpass the $200 billion payday for governments in the 1998 Big Tobacco Litigation settlement.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

Emerging Zinbryta Litigation

Zinbryta (daclizumab) is made and marketed by Biogen and AbbVie. Zinbryta first received FDA approval pursuant to Biologic License Application (BLA: 761029) in May of 2016. Zinbryta is a humanized monoclonal antibody that is self-administered as an injection for the treatment of Multiple Sclerosis.

In March of 2018 Biogen published a letter directed towards physicians and surgeons giving notice that Zinbryta would be withdrawn from the market and would no longer be available as of April 30, 2018.

The emerging Zinbryta Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

Course attendees will receive the benefit of a step by step analysis of the emerging Zinbryta Litigaton, using these primary metrics:

Mass Tort Nexus Metrics

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including James Onder, of The Onder Firm in St. Louis, MO>

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively. Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

Emerging Viberzi Litigation

Viberzi Litigation

Viberzi made by Allergan received FDA approval subsequent to New Drug Application (NDA:206940) in May of 2015.

Since its approval the makers of Viberzi have flooded the media with advertisements, primarily directed toward women, featuring a now familiar female character wearing a jumpsuit featuring print depicting a portion of the human gastro-intestinal system.

FDA Communication Excerpt on Viberzi:

“FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.

Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.”

Viberzi Emerging Litigation

Gallstone disease is one of the most common of all digestive diseases. The U.S. Centers for Disease Control and Prevention estimates that 6.3 million men and 14.2 million women in the United States have gallbladder disease. There is marked variation in the prevalence between ethnic groups

Approximately 700,000 individuals in the U.S. have their gallbladder removed each year.

How to Learn More About the Emerging Viberzi Litigation

The emerging Viberzi Litigation will be used as a case study in the May 18 – 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” to register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

Course attendees will receive the benefit of a step by step analysis of the emerging Viberzi

Litigation, using these primary metrics:

Mass Tort Nexus Metrics

See endorsements below of some of the top mass tort trial lawyers in the country who’ve attended the Mass Tort Nexus Immersion Course>

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively. Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

Emerging Uloric Litigation

Uloric Litigation

Uloric made by Takeda Pharmaceuticals gained FDA approval subsequent to New Drug Application (NDA: 021856) in February 2009.

Takeda Pharmaceuticals is facing multiple Qui Tam lawsuits filed by a former safety consultant for the company. These suits that the company withheld information about dangerous side effects related to Uloric, including kidney problems, liver damage, bone marrow failure, drug interactions and more.

Gout, a type of arthritis that occurs when uric acid crystals build up in the joints. Gout has been found to be more common in men than in women Gout is believed affects about 8.3 million people, or 4% of the U.S. population.

Uloric was the first new drug approved to treat Gout in 40 years. Unfortunately, this new treatment which promised relief for those who suffer from Gout, appears to have numerous significant and potentially life threatening side effects that Takeda never warned the public about.

Learn More About the Emerging Uloric Litigation

The emerging Uloric Litigation will be used as a case study in the May 18-21, 2018 Mass Tort Nexus “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

Course attendees will receive the benefit of a step by step analysis of the emerging Uloric

Litigation, using these primary metrics:

Mass Tort Nexus Metrics

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including CNN Legal Analyst Mark O’Mara>

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively. Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

Emerging Varubi Litigation

VARUBI®(rolapitant) was originally developed by Schering-Plough Corp. and after the merger with Merck & Company they began marketing in November 2009. Tesaro Inc. has since licensed Varubi.

January 2018 FDA Communication Excerpt:

“Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock. Anaphylaxis or anaphylactic shock are serious medical conditions which if not promptly treated can result in death”

Where to Learn More About the Emerging Varubi Litigation

The emerging Varubi Litigation will be used as a case study in the May 18 – 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

Course attendees will receive the benefit of a step by step analysis of the emerging Varubi Litigation using these primary metrics:

Mass Tort Nexus Metrics

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course>

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively. Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

Emerging Nuplazid Litigation

Nuplazid (pimavanserin) made by Acadia Pharmaceuticals Inc. was approved by the FDA in April of 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Based on a review of the FDA adverse event reporting system,(FAERS) more than 5000 adverse events reports have been filed related to Nuplazid since its approval in 2016. Approximately 700 of these adverse event reports involved the death of the patient.

Learn More About the Emerging Nuplazid Litigation

The emerging Nuplazid Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” to register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

Course attendees will receive the benefit of a step by step analysis of the emerging Nuplazid Litigaton, using these primary metrics:

Mass Tort Nexus Metrics

See endorsements below of some of the top mass tort trial lawyers in the country who’ve attended the Mass Tort Nexus Immersion Course>

DARIN SCHANKER, Bachus & Schanker, LLC

JERRY PARKER, Firm Founder, Parker Waichman, LLP

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts is considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively. Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

“FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

By Mark A. York (April 18, 2018)

Former President Bill Clinton Speaks On The Opioid Crisis

(MASS TORT NEXUS MEDIA) Former President Bill Clinton pulled no punches as he focused directly and commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

President Clinton was the keynote speaker at the National Rx Drug Abuse & Heroin Summit, which drew more than 3,000 experts in fields such as addiction treatment, law enforcement and medicine from across the country recently in Atlanta. He shared his own personal experiences as well as voicing his opinions on opioid solutions and strategies that work and the many challenges facing the country in the future.

He was very clear when stating that there’s no room for stigma in the face of such an urgent and widespread problem. Nearly every family is touched by the issue — including his. Not only does he have family members who have struggled with drug abuse, he said at least five close friends have lost children and family members to overdoses, including two native Arkansans, first-generation immigrants from India and Kosovo and African-American preachers. This is the common thread in the opioid crisis fabric, there is no social or demographic group that is exempt from the epidemic.

“Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game issue of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered.

From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

The former president referred to the work done by his Clinton Foundation, who’ve provided both training and resources to communities fighting addiction and makes the opioid antidote naloxone more available to the public at a low cost.

He discussed programs elsewhere that he believes work well, including a unique medical system in eastern Pennsylvania where no doctors prescribe opioids. When a patient comes in who may legitimately need the painkillers, a panel headed by a highly educated pharmacist looks at that option as well as other alternatives. The panel does all the opioid prescribing, he said, and opioid prescriptions have dropped dramatically.

Clinton praised community health centers, local county health units and faith based community groups who are spearheading efforts in in caring for people struggling with addiction. He said grass roots solutions often work best because each place is different, and its residents know it best.

He also added the United States as a whole faces many challenges, including the rise of the deadly synthetic opioid fentanyl, which is making its way “into the bloodstream of America” from China. He said the United States “ought to get the Chinese to help us” and must also do more to stop the heroin flowing in from Mexico. Many others in government have directed attention to the Chinese government for help, but to date, there has been very limited assistance from China on this.

He further stated that the country must do more to reduce demand for drugs. And that will mean addressing issues at the root of addiction, such as hopelessness and poverty. Many overdose victims, he said, are ultimately “dying of a broken heart.” How treatment programs can be more widely accepted as well as becoming approved as a disease treatment versus a “drug addict” problem, remains to be seen.

“The roots of this are deep in our soul,” Clinton said. “You know it and I know it.”

During the Clinton years in office, he enacted various drug control programs and strategies which primarily focused on drug abuse prevention, drug use education, drug treatment and enforcement. Clinton White House archives, show he elevated the position of “drug czar” to a cabinet-level post, expanded drug courts, provided funding across the country and stepped up drug-related enforcement efforts. To support these programs and efforts, overall funding for anti-drug efforts rose from $12.2 billion in 1993 to $18.5 billion in 2000.

Although there were critics the time, many were determined to be politically motivated and more of a rhetorical attack on Bill Clinton politics as a whole. These included the 1994 report by the conservative Heritage Foundation titled, “How the Clinton Administration is Abandoning the War Against Drugs,” which falsely claimed Clinton’s “new direction will allow more cocaine, heroin and marijuana to reach American streets, and it will cut federal enforcement personnel.” Which simply furthered the now misguided correlation between marijuana use and hard drugs. The group also said one of the first announced goals of then-Attorney General Janet Reno was to reduce mandatory minimum sentences for drug trafficking and other related crimes, sentences the group argued “put teeth in drug enforcement.” This has been proven to be inaccurate and a distortion of the attempts to bring crime and punishment more in line with the times and how criminal sentencing were applied in lower economic areas of the country.

Clinton said today’s fight against drugs must be a bipartisan effort that pulls together Americans from all parts of the political spectrum. Although this would be a sincere effort to bring political parties together to address a problem that is now firmly implanted across the United States.

“We can do this. And it will be really good for us, because it’s about time we did something together again,” he said. “Last time I checked, anytime we did anything together, we never lost.” Mr. Clinton’s stance on a joint effort to address the opioid crisis seems genuine, but based on the many views within the current DC political world, beginning with President Trump and his view that the problem is drug users versus taking a step back view that society itself along with Big Pharma are accountable for the current opiate epidemic.

What the solutions are for solving the Opioid Crisis across the country remain to be seen and as stated by President Clinton “nobody gets out for free.”

“New Jersey State Court Opens Ethicon Hernia Mesh Consolidation”

Mark A. York (April 17, 2018)

(MASS TORT NEXUS MEDIA) Ethicon’s Pelvic Repair System litigation also known as Transvaginal Mesh (TVM) litigation, (see Mass Tort Nexus Ethicon TVM MDL 2327 Briefcase) and the more recent hernia mesh legal filings, are the latest in a series of ongoing legal battles facing Johnson & Johnson and its Ethicon subsidiary. Ethicon is facing over 50,000 mesh lawsuits in state and federal courts across the country where plaintiffs have filed suits over their synthetic mesh surgical implants. The numbers are increasing daily as the TVM plaintiffs are being joined by plaintiffs filing “hernia mesh” lawsuits, where the allegations are very similar to claims asserting that J&J’s failed to warn and choosing to ignore the thousands of FDA filed adverse events related to its hernia mesh products.

EMERGING NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

Ethicon TVM litigation has been underway for close to six years in MDL 2327, (MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation court link) currently pending in the U.S. District Court in West Virginia, where U.S. District Judge Joseph Goodwin is also overseeing seven other multidistrict litigations (MDLs) established for cases against different manufacturers. When you add in other synthetic mesh manufacturer lawsuits besides J&J, there are more than 100,000 mesh lawsuits pending against Ethicon and other manufacturers, including Boston Scientific, C.R. Bard, American Medical Systems (AMS) acquired by Endo, Coloplast, Cook Medical, Neomedic and others.

Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Only American Medical Systems, Inc has resolved substantially all of their claims over their mesh products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.

PRIOR MESH SETTLEMENTS

While manufacturers have had some success in defending the safety of the products in a handful of cases, most of the claims that have gone before a jury so far have resulted in substantial damage awards, suggesting that TVM settlements will likely cost the companies several billion dollars. There have been settlements by some mesh makers including End International, Inc. on behalf of American Medical Systems, Inc, where Endo agreed to pay $775 million in August 2017 to resolve the remaining cases, where there had been over 22,000 lawsuits filed over its vaginal mesh implants. They had previously agreed to a $400 million settlement of more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. This has been part of Endo’s decision to exit “substantially all” the remaining lawsuits against its AMS unit, with the $400 million being in addition to $1.2 billion previously pledged by Endo to cover mesh litigation. Including its $830 million settlement to resolve thousands of mesh lawsuits (~40,000 per case) in May 2014. That settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny.

ETHICON TRIAL VERDICTS

Although Ethicon attempts to defer blame and causation for the often life altering medical conditions that occur post mesh implant surgery, they are often found liable at trial with verdicts being anywhere from $1.5 million to more than $100 million and often include major punitive damages. The punitive damages, which are designed to punish Ethicon for conducting its business with malice towards women who were implanted with the products, finding that the company knew that the synthetic mesh products caused severe complications, but failed to warn the medical community.

With Ethicon (Johnson & Johnson) facing more vaginal mesh lawsuits than any other manufacturer. Here are trial verdicts from lawsuits that have resulted in major losses for Ethicon/J&J again and again:

In March 2018, a jury in Indiana awarded $35 millionto Barbara and Anton Kaiser. They’d sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. They awarded her $10 million in damages and hit Ethicon with $25 million in punitive damages.

In December 2017, a Bergen County, NJ jury awarded$15 million to Elizabeth Hrymoc. Ms. Hrymoc said she received a defective Prolift mesh implant in 2008, which left her in such pain that she had to have it removed and replaced. She cried as the jury announced their verdict.

In September 2017, a Philadelphia jury awarded $57.1 millionto Ella Ebaugh, who says she suffered chronic pain and incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ms. Ebaugh says she required three surgeries to remove the mesh. Ethicon vowed to appeal.

In April 2017, a Philadelphia jury awarded $20 millionto a woman who claimed she was in constant pain because of her TVT-Secur transvaginal mesh, a product of Johnson & Johnson subsidiary Ethicon. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.

$13.5 million verdict awarded to Sharon Carlino of New Jersey in February 2016. According to the lawsuit, Carlino received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence and it left her with constant pain and discomfort. Two surgical attempts to fix the device did not rid her of pain. $10 million of the verdict came in the form of punitive damages. The jury said that Carlino’s doctor would not have used the Ethicon mesh had the device risks been known.

$4.4 million jury award to Florida resident Tessa Taylor in February 2016. The jury found that ObTape sling (made by J&J subsidiary Mentor) caused Taylor’s back pain, bladder pain, and difficulty urinating over a 7 year period. Taylor received the mesh to treat urinary incontinence, but she was re-diagnosed with the condition in spite of the device. $4 million of the verdict was for punitive damages to “discourage others from behaving in a similar way.”

J&J agreed to pay $120 million to settle 2,000-3,000 mesh lawsuitsin January 2016. The settlement marked the first serious attempt by J&J to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still faced more than 42,000 mesh cases.

$5 millionsettlement reached in September with plaintiff Pamela Wicker, implanted with Ethicon’s Prolift mesh device. Wicker claims that Prolift eroded inside of her and necessitated numerous surgeries to remove the device. A law professor said that the large settlement showed the costs of dealing with mesh litigation would be a lot higher than expected.

$5.7 millionverdict awarded to Coleen Perry in March 2015 by a California jury. Perry was implanted with the J&J/Ethicon TVT Abbrevo and says she expects to have pain the rest of her life. The jury found that the TVT Abbrevo has design problems and that Ethicon failed to warn about potential health risks. The verdict included $5 million in punitive damages for conduct that amounted to “malice.”

Two confidential settlementsinvolving 115 mesh victims were reached in January 2015. One of the settlements resolved 4 cases in Missouri over Ethicon’s Prolift mesh device and the other resolved 111 cases in Georgia over the ObTape Transobturator Sling (made by J&J subsidiary Mentor). The Missouri women claimed that the mesh in Ethicon’s Prolift insert shrinks and damages organs, causing constant pain and making sexual intercourse difficult, while the Georgia women alleged that ObTape causes permanent injuries.

$3.25 millionverdict awarded to plaintiff Jo Husky over the J&J/Ethicon Gynecare TVT-O mesh device. The verdict was reached by a West Virginia jury in September 2014 following a two-week trial. Jurors found that the TVT-O was faulty and that Ethicon failed to warn of side effects.

$1.2 millionverdict awarded to Linda Batiste, implanted with the Gynecare TVT Obturator (TVT-O) mesh sling (made by J&J unit Ethicon) in April 2013. The jury concluded that the device’s design was flawed.

$11.1 millionverdict (including $3.35 million in compensation and $7.76 million in punitive damages) awarded to Linda Gross of South Dakota, who was implanted with J&J’s Gynecare Prolift vaginal mesh device. A New Jersey jury reached the verdict in February 2013, saying that J&J fraudulently misled Gross about device risks.

ETHICON MESH LITIGATION

Judge Goodwin is overseeing coordinated pretrial proceedings for all federal vaginal mesh lawsuits, as the cases involve nearly identical allegations that the products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women are defectively designed and can cause severe and deforming complications, including infections, puncturing organs and eroding through the vagina.

The MDLs were established for cases against each manufacturer to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts. However, as hundreds of cases become “trial ready”, and manufacturers continue to make little progress in settling claims, Judge Goodwin faces the prospect of remanding large numbers of lawsuits back to U.S. District courts nationwide for individual trials, which could take decades to complete.

Plaintiff complaints against Ethicon all consistently assert that Ethicon was and is aware of the dangers posed by their synthetic mesh products, and choose to ignore the thousands of adverse event reports filed with the FDA as well as the fact that more than 50,000 plaintiffs have filed lawsuits over Ethicon synthetic mesh implants. The legal claims assert injuries due to the defective design of the most every synthetic mesh product made by Ethicon regarding its vaginal mesh, including mesh erosion, mesh contraction, inflammation, pain during sexual intercourse, urinary incontinence, chronic pain, and recurring prolapse of organs.

As a result of the post surgical complications, plaintiffs have been known to undergo as many as four operations to have the mesh removed, often resulting in massive levels of pain as well as financial impact of repeated surgeries and rehabilitation. There are many instances where the the surgeons were unable to remove all the mesh due to the mesh adhesion to internal organs and surfaces within the body that were never intended as a post surgical complication.

While the outcome of the MDL cases and other trials are not binding on other cases in the vaginal mesh litigation, Ethicon and its parent Johnson & Johnson should gauge how juries have responded to certain evidence and testimony via recent major trial verdicts in most every mesh trial they’ve faced in both federal and state courts. How Ethicon counsel views the recent trial verdicts and the impact on the thousands of other cases they face, and the potential for the trial results to be repeated throughout these cases, would seem to have an impact on J&J’s views of starting substantive settlement negotiations. To date, this has not been a significant part of the Johnson & Johnson legal business strategy, potentially resulting in an ongoing windfall for the thousands of plaintiffs for years to come.

(MASS TORT NEXUS MEDIA) In a very loud and direct voice, Johnson & Johnson and their talc supplier, Imerys SA suffered an additional $80 million in punitive damages award on top of the initial $37 million jury verdict awarded last week. This brings the total trial verdict to $117 million they must pay to a retired New Jersey husband and wife, after a trial found that plaintiff Stephen Lanzo’s decades long use of J&J talcum powder products caused him to be afflicted with mesothelioma. A fatal form of cancer not often affiliated with use of talcum powder products.

The Middlesex County, New Jersey, jury ordered the companies to pay $80 million in punitive damages Wednesday, after post-trial arguments on punitive damages. Last week, the jury awarded the Mr. Lanzo $30 million in compensatory damages and his wife $7 million in damages.

Lanzo claims his use of Johnson & Johnson name brand products like Shower to Shower and Baby Powder for more than 30 years, and that inhaling the powder caused his mesothelioma, an aggressive and deadly cancer that impacts the lining of the lungs. The $80 million in punitive damages in J&J’s home state of New Jersey, where traditionally they have avoided adverse trial verdicts, and enjoyed a “home team” sense of security, may now send a message J&J’s withholding of scientific data and information that shows their consumer product have dangers and the company has been aware for decades has come full circle.

Deposits of talc, one of Earth’s softest minerals are often located near deposits of the minerals that constitute asbestos, and studies have shown the risk of cross-contamination during mining. Johnson & Johnson said its talc products do not contain asbestos, which, it noted, has been a legal requirement since the 1970s.

SCIENCE SAYS TALC IS DANGEROUS

The debate over talc began decades ago. In the early 1970s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data then publicly declared this research as flawed, which J&J still continues to this day.

As other talcum powder meso cancer cases are pending in courts across the country, with one set to go to trial in May in South Carolina, J&J and its affilaites may have to gear up to defend a flood of additional new cases if the talc-meso linked plaintiff verdicts continue, jury in California found in favor of Johnson & Johnson in an asbestos-related case in November 2017.

Lanzo’s case was the first to go to trial in New Jersey, where of Johnson & Johnson is headquartered, with the trial taking place in a state court versus a more traditional federal venue, where J&J are more accustomed to defending their consumer, pharmaceutical and medical device product line. If all pending litigation against J&J and its affiliated divisions for their products are totaled, you will find that the number of lawsuits being defended by J&J easily surpasses 100 thousand individual lawsuits filed in federal and state courts across the country.

Johnson & Johnson and other talcum powder companies face thousands of talcum powder cancer lawsuits elsewhere that draw a connection between genital talc use and ovarian cancer, where there are been massive verdicts as high as $400 million last year in California and in a St Louis courtroom where talcum powder ovarian cancer verdicts have totaled over $300 million in the last three years.

Johnson & Johnson is facing hundreds of additional lawsuits in a federal multi-district litigation also in New Jersey, see Johnson & Johnson Talcum Powder MDL 2738 (USDC New Jersey), this litigation is related primarily to the ovarian cancer claims brought by women across the country, who claim that J&J talcum powder products cause ovarian cancer, which combined with the emerging talc mesothelioma lawsuits, would open an entire new area of mass tort litigation for J&J and its affiliates to defend.

The Lanzos’ lawyers accused the company of holding back information from its customers about the health risks of asbestos in its talc products since the 1960s. This has bene a key plaintiff legal strategy in most every case against J&J, as they have been found to have made concerted and boardroom facilitated efforts to suppress and change public opinion about their product dangers.

Efforts to conceal this fact included J&J’s paying respected medical, science and other respected researchers to write and publish article and research papers mitigation the adverse findings posted in independent journals alleging that asbestos was found in talc products. Trial testimony also showed that J&J had made multiple and unsuccessful attempts to remove asbestos from their talc products, dating back to the 1970’s, yet at trial they claimed there was no asbestos risk in their talcum powder products. With one defining trial comment being “Why do you try so hard to get it out, it’s because it is there,” which would seem to define plaintiff claims that J&J was aware of the risks long ago.

Johnson & Johnson argued that it did extensive testing to make sure its products were not contaminated. The science J&J relies on has been the subject of research since at least 1975 and many times the findings were found to be adverse to the consumer product giants sales and marketing agenda, and were often discredited by an organized corporate strategy.

“Johnson’s Baby Powder has been used for more than 120 years and it does not contain asbestos or cause mesothelioma,” the company offered. “After suffering multiple losses through court rulings and at trial, plaintiff’s attorneys have shifted their strategy and are now alleging that talcum powder is contaminated with asbestos, despite multiple independent, non-litigation-driven scientific evaluations which have found that our baby powder does not contain asbestos.

“Throughout this trial, we were prevented from presenting evidence we believe would have been important to the jury in their deliberations, which forced us to file multiple mistrial motions. We will continue to defend the safety of Johnson’s Baby Powder and immediately begin our appeal, and we believe that once the full evidence is reviewed, this decision will be reversed.”

The Lanzo trial started on January 29, 2018 and was closely watched as the first “talc” lawsuit to go to trial in Johnson & Johnson’s home state over allegations that talcum-based hygiene products like Baby Powder and Shower to Shower contained asbestos and that J&J failed to warn of the risk as well as hid data that showed asbestos was in its products. The asbestos allegations are now an evolving legal fight for J&J, as most prior litigation over its Baby Powder and Shower to Shower products were over claims that the products have caused ovarian cancer in women. Those 5 cases case have been in the Missouri and California state courts over the last 2 years, with plaintiffs winning all but 1 of those trials, see J&J Talcum Powder Litigation, Missouri State Court, St Louis County Docket.

J&J DID WIN 1ST CALIFORNIA MESO TRIAL

Of note is the California court trial verdict of November 16th where J&J did win a victory in the first mesothelioma trial; where J&J and co-defendant Imerys Talc America successfully defended claims by plaintiff Tina Herford that J&J’s Baby Powder caused

Suppressing adverse research findings and manipulating science related to discoveries that Johnson & Johnson products pose significant health risks are cornerstones of most litigation against J&J and its various medical products divisions, often resulting in much higher verdicts based on the intentional failure to warn and failure to disclose the dangers to consumers. Often the trial data shows that J&J has been aware of many dangers as far back as the middle 1970’s, and yet they went to extraordinary lengths to suppress this information from being released to the marketplace and consumers.

J&J was defended by the Chicago firm of Kirkland & Ellis LLP a highly respected and very aggressive defense firm, who are rather new to the J&J world of medical device litigation and were unsuccessful. They argued that any link between talc products and mesothelioma is based on the tried and sometimes untrue defense of faulty testing methods, and plaintiff claims of limited and outdated studies, defense counsel even went so far as to state that Lanzo was exposed to asbestos in his childhood home and at school.

Defense claimed that J&J’s products never contained asbestos, and that they have performed careful testing to confirm that, which based on the jury verdict fell on deaf ears.

WHO’S LIABLE IF MESO-TALC LITIGATION EXPLODES

While the ovarian cancer cases have dominated the headlines, the cosmetic talc asbestos contamination cases may present the bigger risk to defendants and a much greater reward to plaintiff counsel. Thousands of companies used cosmetic talc in their products over the last hundred years. The entire population could claim exposure, especially to defendants that sold personal care products that could be ingested, inhaled or exposed via air-borne contact. The risk is that the cosmetic talc defendants become the defendant of last resort when a plaintiff has no other convincing credible sources of exposure to asbestos, especially when the original product source is now a bankrupt entity.

Science of Cosmetic Talc Claims: While it may be difficult to challenge long-established trigger approaches if a talc claim involves a claim of asbestos contamination, ovarian cancer talc claims may require a new look at trigger issues because the underlying science of how talc exposure may cause ovarian cancer is different from how asbestos inhalation damages the respiratory system. Having learned from previous trigger battles in asbestos, the insurers are likely to challenge the science that the first exposure to cosmetic talc causes injury that can be associated with the development of ovarian cancer and characterized as “bodily injury” as required in their policies. They may seek out scientific opinion that ovarian cancer caused by cosmetic talc is not progressive in nature, and thus not warranting the imposition of a continuous trigger. And, generally, the insurers will likely seek to limit the spread of potentially triggered policies to as few years as possible, and as close to the manifestation of the disease as possible.

DOES J&J TALCUM POWDER CAUSE CANCER?

Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just 5 trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.) J&J is notorious for using any means possible to influence scientific data and opinion as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually awarded for intentional misconduct, see “New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years as part of the National Institutes of Health’s well-respected Women’s Health Initiative.

IS “MESOTHELIOMA TALC” THE NEW MASS TORT?

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the earlier J&J talc cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

Will “Talc Mesothelioma” be the next mass tort against Johnson & Johnson and its affiliates? Mass Tort Nexus will continue to report on this as additional information becomes available.

J&J NOT FARING WELL IN 2018 TRIAL VERDICTS AS PLAINTIFFS WIN AT TRIAL AGAIN

By Mark A. York (April 6, 2018)

(MASS TORT NEXUS MEDIA) Johnson & Johnson was hit again in a courtroom. This time for $37 million in New Jersey state court, where a jury found that J&J’s talcum powder based products contain asbestos and caused the male plaintiff Stephen Lanzo to develop mesothelioma, a fatal cancer. The “talc” verdict occurred late Thursday, April 5, 2018 before Judge Ana C. Viscomi, who presides over the state’s centralized asbestos docket, closely followed the March 8th trial verdict against J&J for $35 million in the J&J Ethicon Pelvic Mesh trial, which found that J&J hid the dangers of its synthetic surgical mesh products. In the Lanzo talc trial, Johnson & Johnson and its talc supplier were found to have caused the plaintiff to develop mesothelioma, after using the pharmaceutical giant’s asbestos-containing talcum powder over several decades. The case docket entry is Lanzo v. Cyprus Amex Minerals Co, et al., Docket No. L00738516 in Middlesex County Superior Court, Judge Anna C. Viscomi.

Johnson & Johnson is facing hundreds of additional lawsuits in a federal multi-district litigation also in New Jersey, see Johnson & Johnson Talcum Powder MDL 2738 (USDC New Jersey), this litigation is related primarily to the ovarian cancer claims brought by women across the country, who claim that J&J talcum powder products cause ovarian cancer, which combined with the emerging talc mesothelioma lawsuits, would open an entire new area of mass tort litigation for J&J and its affiliates to defend.

The Lanzo trial started on January 29th and was closely watched, as the first “talc” lawsuit to go to trial in Johnson & Johnson’s home state over allegations that talcum-based hygiene products like Baby Powder and Shower to Shower contained asbestos and that J&J failed to warn of the risk as well as hid data that showed asbestos was in its products. The asbestos allegations are now an evolving legal fight for J&J, as most prior litigation over its Baby Powder and Shower to Shower products were over claims that the products have caused ovarian cancer in women. Those five cases case have been in the Missouri and California state courts over the last 2 years, with plaintiffs winning all but one of the trials, see J&J Talcum Powder Litigation, Missouri State Court, St Louis County Docket.

J&J WON FIRST CALIFORNIA TALC MESO TRIAL

Of note, is the California court trial verdict from November 16, 2017 where J&J did win a victory in the first mesothelioma trial; where J&J and co-defendant Imerys Talc America successfully defended claims by plaintiff Tina Herford that J&J’s Baby Powder caused her to be stricken with mesothelioma, after 35 years of using their products daily..

The New Jersey trial was the first case that went to trial, where a male plaintiff has asserted cancer causing claims involving J&J’s talc products. Plaintiff Stephen Lanzo, 46, claimed that after using Johnson’s Baby Powder for decades and inhaling asbestos particles within the product, he developed mesothelioma. The primary claims against J&J and their talc supplier Imerys Talc America is that the companies knew their cosmetic talc products contained asbestos, but failed to warn consumers and intentionally suppressed scientific research that showed asbestos was contained within their talc based products.

Suppressing adverse research findings and manipulating science related to discoveries that Johnson & Johnson products pose significant health risks are cornerstones of most litigation against J&J and its various medical products divisions, often resulting in much higher verdicts based on the intentional failure to warn and failure to disclose the dangers to consumers. Often the trial data shows that J&J had been aware of many dangers, as far back as the middle 1970’s, and yet they went to extraordinary lengths to suppress this information from being released to the marketplace and consumers.

J&J and Imerys defended against Lanzo’s mesothelioma claims by asserting that the his condition was caused by of exposure to asbestos from other sources, and that the talc used in J&J’s products never contained asbestos. During the trail Mr. Lanzo’s trial counsel described in detail, as well as by showing documents obtained from J&J and other legally accepted science and research sources, that talc and asbestos occur naturally together, and that J&J knew as early as the 1970’s that their cosmetic talc products contained asbestos.

Efforts to conceal this fact included J&J’s having paid respected medical, science and other prominent industry researchers to write and publish articles and research papers mitigating the adverse findings posted in independent journals alleging that asbestos was found in talc products. Trial testimony also showed that J&J had made multiple and unsuccessful attempts to remove asbestos from their talc products, dating back to the 1970’s, yet at trial they claimed there was no asbestos risk in their talcum powder products. With one defining trial comment being “Why do you try so hard to get it out, it’s because it is there” which would seem to define plaintiff claims that J&J was aware of the risks long ago.

J&J was defended by the Chicago firm of Kirkland & Ellis LLP a highly respected and very aggressive defense firm, who are rather new to the J&J world of medical device litigation and were unsuccessful. They argued that any link between talc products and mesothelioma is based on the tried and sometimes untrue defense of faulty testing methods, and plaintiff claims of limited and outdated studies. Defense counsel even went so far as to state that Lanzo was exposed to asbestos in his childhood home and at school.

Defense claimed that J&J’s products never contained asbestos, and that they have performed careful testing to confirm that, which based on the jury verdict fell on deaf ears.

DOES J&J TALCUM POWDER CAUSE CANCER?

Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just five trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.) J&J is notorious for using any means possible to influence scientific data and opinion,only as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually only awarded for intentional misconduct, see “New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

SCIENCE SAYS TALC IS DANGEROUS

The debate over talc began decades ago. In the early 1970’s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data, then publicly declared this research as flawed, which J&J still continues to this day.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years, as part of the National Institutes of Health’s well-respected Women’s Health Initiative.

WILL “MESOTHELIOMA TALC” BE THE NEW MASS TORT?

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma, due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the J & J cases. Further, both juries found that the defendants acted with malice; however, the cases were confidentially settled before the respective punitive damage phases.

Who’s Liable if Industrial Talc Litigation Explodes

While the ovarian cancer cases have dominated the headlines, the cosmetic talc asbestos contamination cases may present the bigger risk to defendants and a much greater reward to plaintiff counsel. Thousands of companies used cosmetic talc in their products over the last hundred years. The entire population could claim exposure, especially to defendants that sold personal care products that could be ingested, inhaled or exposed via air-borne contact. The risk is that the cosmetic talc defendants become the defendant of last resort when a plaintiff has no other convincing credible sources of exposure to asbestos, especially when the original product source is now a bankrupt entity.

Science of Cosmetic Talc Claims: While it may be difficult to challenge long-established trigger approaches if a talc claim involves a claim of asbestos contamination, ovarian cancer talc claims may require a new look at trigger issues because the underlying science of how talc exposure may cause ovarian cancer is different from how asbestos inhalation damages the respiratory system. Having learned from previous trigger battles in asbestos, the insurers are likely to challenge the science that the first exposure to cosmetic talc causes injury that can be associated with the development of ovarian cancer and characterized as “bodily injury” as required in their policies. They may seek out scientific opinion that ovarian cancer caused by cosmetic talc is not progressive in nature, and thus not warranting the imposition of a continuous trigger. And, generally, the insurers will likely seek to limit the spread of potentially triggered policies to as few years as possible, and as close to the manifestation of the disease as possible.

Exceptional advancements in the science of diagnosing and predicting cancer in the last few years will provide plaintiffs, policyholders and insurers the opportunity to craft new trigger theories to their advantage and to circumvent past judicial decisions that were to their disadvantage. We have already seen the insurance industry using alleged advancements in asbestos science to attempt to limit the scope of historical “occurrence” policies. There is no insurance precedence with respect to trigger and talc ovarian cancer claims. Expect both sides to bring new experts and theories with respect to biologic and genomic issues, including molecular cancer experts opining about genetic alterations pre-existing before manifestation of a tumor. Resolution of these issues will be especially challenging because much less is known about females’ “defense systems” as opposed to airborne exposure through the lungs.

The science of ovarian cancer cosmetic talc claims is likely different from asbestos claims, but that will be a question for the experts and courts. Because plaintiffs will have an easy time in most cases demonstrating exposure to consumer products (e.g., for baby powder, theoretically from birth to present), both kinds of cosmetic talc claims generally would be linked together based on length and type of exposure.

Will “Talc Mesothelioma” be the next mass tort against Johnson & Johnson and its affiliates? Mass Tort Nexus will report on this as additional information becomes available.